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Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis (PACT)

8. november 2010 opdateret af: University of Glasgow

A Pilot Randomised Controlled Trial of Acceptance and Commitment Therapy for Distress Following Psychosis

This research investigates a new talking therapy aimed at helping people to come to terms with the experience of psychosis. The new therapy is called Acceptance and Commitment Therapy for psychosis (PACT). PACT aims to help people:

  1. Develop a sense of "mindfulness." Mindfulness allows you to be fully aware of your here-and-now experience, with an attitude of openness and curiosity. It is hoped that this will help reduce the impact of painful thoughts and feelings.
  2. Take effective action that is conscious and deliberate, rather than impulsive. It is hoped that this will allow people to be motivated, guided, and inspired by the things that they value in life.

It is hoped that PACT will help to reduce the level of distress that individuals diagnosed with psychosis have been experiencing and help them to stay well in the future.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Emphasis has been placed on treating the 'positive symptoms' of psychosis (e.g. hallucinations and delusions). Concordance rates with anti-psychotic medication can be low. Even when positive symptoms are successfully treated, emotional distress can remain e.g. depression, anxiety and trauma. Relapse occurs in up to two thirds of patients within two years of the first episode. The treatment of subsequent episodes has been shown to be progressively less efficacious. Research has shown that fear of recurrence patients can experience following psychosis is predictive of relapse. Randomised clinical trials have found that Cognitive Behaviour Therapy (CBTp) is efficacious for treating residual distressing positive and negative symptoms. However, the evidence for treating emotional dysfunction (e.g. social anxiety, post-psychotic depression) is less clear. Acceptance and Commitment Therapy (ACT) incorporates acceptance and mindfulness elements into a CBT framework. Rather than altering the content or frequency of cognitions, ACT seeks to alter the individual's psychological relationship with thoughts, feelings and sensations to promote psychological flexibility. This research will be a pilot randomised control trial of ACT for treating distress following psychosis. This pilot study will establish (a) whether a larger scale multi-centre randomised controlled trial is warranted, (b) the acceptability of Acceptance and Commitment Therapy (c) the expected primary and secondary outcomes for such a trial and (d) the sample size required to detect such outcomes. It is hypothesised that ACT plus treatment as usual will be associated with a greater reduction in levels of distress than treatment as usual only.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

27

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Scotland
      • Glasgow, Scotland, Det Forenede Kongerige, G3 8YZ
        • Greater Glasgow and Clyde NHS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participants will meet DSM-IV-TR (APA, 2000) criteria for a psychotic disorder determined by a diagnosis of a psychotic disorder (i.e., Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS) or Bipolar Disorder (with psychotic features).
  • Participants will also be aged 18-65

Exclusion Criteria:

  • Participants will be excluded if there is a

    • diagnosis of learning disability
    • inability to participate in psychotherapy/research due to acute medical condition or florid psychosis (as defined by a score of 5 or over on the Positive Syndrome scale of the PANSS)
    • psychotic symptoms due to a general medical condition
    • they are receiving a systematic psychological therapy at the point of recruitment/randomization.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Treatment As Usual
Treatment as usual as determined by the clinical team responsible for the individual's care
Aktiv komparator: Acceptance and Commitment Therapy
Up to 10 sessions of Acceptance and Commitment Therapy plus treatment as usual
Andet: Acceptance and Commitment Therapy
Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy
Andre navne:
  • HANDLING

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measuring change in depression and anxiety
Tidsramme: Baseline and 3 month follow-up
The Hospital Anxiety and Depression Scale
Baseline and 3 month follow-up
Changes in believability, distress and frequency of positive symptoms
Tidsramme: Baseline and up to 9 months follow-up
Baseline and up to 9 months follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measuring change in mindfulness skills and psychological flexibility
Tidsramme: Baseline and up to 9 month follow-up
The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire
Baseline and up to 9 month follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Glasgow

Samarbejdspartnere

NHS Greater Glasgow and Clyde

Efterforskere

  • Ledende efterforsker: Ross G White, BSc, PhD, DClinPsy, University of Glasgow

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

27. oktober 2009

Først indsendt, der opfyldte QC-kriterier

27. oktober 2009

Først opslået (Skøn)

28. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. november 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2010

Sidst verificeret

1. november 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PN09CP213
  • Ethics Ref:09/S0701/74

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Acceptance and Commitment Therapy

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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